Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lithuania.
Notas adicionales en la data
Causa
Test tubes (neither commercial packaging nor individual label) shall bear the ce marking of conformity and the number of the notified body, which does not comply with the requirements of points 60 and 61 of the ivd regulation; the name and address of the authorized representative in the european economic area are not specified, which is not in line with the requirement of annex 1, paragraph 13.4.1 of the ivd regulation.
Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lithuania.
Notas adicionales en la data
Causa
The goods are not labeled with any information (implants are packed in transparent plastic bags without labels), so their labeling does not meet the requirements of annex 1, paragraph 14 of the regulation.